Engineer

Join Amgen’s Mission of Serving Patients 

At Amgen, if you feel likeyou’repart of something bigger,it’sbecause you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. 

Since 1980,we’vehelped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year.Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rarediseases, andobesity and obesity-related conditions.As a member of the Amgen team,you’llhelp make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. 

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them,you’llthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 

Engineer

What you will do

Let’sdo this.Let’schange the world. In this vital role you willjoin ourDeviceEngineering group to supportchange control, engineering robustness, anddevice development.  In support of Amgen’s mission to serve patients, the Device Engineering group at Amgen is a diverse team working toidentify, develop, commercialize, and continuously improve drug delivery devices tooptimizethepatientexperience. 

The role willbe responsible fordriving and coordinating complex, cross-functional product development efforts, with clear ownership for managing interactions, dependencies, and interfaces to ensure program execution.  The successful candidate will be a key member of the technical team that progresses towards the design, development, and transfer of drug delivery devices. The role ensures that the quality targets are satisfied,identifiestechnical risks and coordinates risk retirement activities on the program.

The position is based at our Amgen Massachusetts site with the possibility of a flexible working arrangement meeting business and private needs. You will be joining Amgen’s device development team consisting of 50+ engineers.

Responsibilities:

The Engineer will be primarily responsible for end-to-end execution of Change Controls, withadditionalresponsibilities supportingrobustnessengineering and design transfer activities. Specifically, the Engineer will:

• Lead end-to-end preparation and execution of Change Controls, including defining scope, rationale, and supporting documentation

• Partner with Change Owners, Document Owners, and SMEs to align timelines, impact assessments, and approvals

• Author and/or support redlining and finalization of controlled documents

• Ensure completeness, accuracy, and compliance of change records within the Quality Management System

• Support presentation of changes at Change Control Boards (CCBs)

• Support development and maintenance of the Design History File

• Supporttasks within one or more of the Design forRobustness disciplines:Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM

• Collaborate across robustness disciplines toidentifyrisks and mitigations, opportunities,and best trade-off solutions

• Collaborate closely with manufacturing, quality, and suppliers to improve product robustness and reduce variation-driven failures

• Apply systems-level thinking to anticipate how design decisionsimpact downstreammanufacturability and performance

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. Thedynamicprofessional weseekis an individualwith these qualifications. 

Basic Qualifications:

• Master’s degree
  OR
  Bachelor’s degree and 2 years ofEngineerexperience
  OR 

• Associate’s degree and 6 years ofEngineerexperience
  OR  

• High school diploma / GED and 8 years ofEngineerexperience 

Preferred Qualifications:

• 2+ years of progressive experience as an engineer or scientist within a research & development, manufacturing, or engineering environment

• Experience with change control and configuration management in regulated environments

• Experience authoring technical documentation and working within a QMS

• Experience in medical device or combination product development under DesignControls

• Understanding of manufacturing processes (e.g., injection molding, assembly processes)

• Familiarity with technical drawings and specifications

• Working knowledge of relevant standards (21 CFR 820, ISO 13485, ISO 14971)

• Strong communicationand cross-functional collaboration skills

• Ability to work with teams across functional areas, cultures, and time zones

• Fluent in English language

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture,we’llsupport your journey every step of the way. 

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